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目的检测基因重组球状脂联素蛋白(gAd)蛋白的经口毒性和遗传毒性,为其临床应用提供医学毒理学依据。方法按照GB15193-2003《食品安全性毒理学评价程序和方法》进行急性经口毒性试验、Ames试验、小鼠骨髓嗜多染红细胞微核试验及小鼠精子畸形试验。结果急性经口毒性试验中实验组动物7d内未见中毒症状,LD50>10g/kg体重。Ames试验中各组回变菌落数均未超过自发回变菌落数2倍,且无剂量反应关系,结果为阴性。骨髓微核试验中各剂量组雌雄性别微核形成率与阴性对照结果比较,差异无统计学意义P均>0.05),结果为阴性。小鼠精子畸形试验中各实验组与阴性对照组结果比较,差异无统计学意义(P均>0.05),精子畸形试验结果为阴性。结论基因重组gAd蛋白属实际无毒级物质,未见遗传毒性作用。
Objective To detect the oral toxicity and genotoxicity of the gene recombinant globular adiponectin (gAd) protein and provide the basis of medical toxicology for its clinical application. Methods Acute oral toxicity test, Ames test, mouse bone marrow polychromatic erythrocyte micronucleus test and mouse sperm abnormality test were conducted according to GB15193-2003 Food Safety Toxicology Evaluation Procedure and Method. Results Acute oral toxicity test in the experimental group of animals showed no symptoms of poisoning within 7d, LD50> 10g / kg body weight. In the Ames test, the number of colonies returned by each group did not exceed 2 times the number of spontaneous return colonies, and no dose-response relationship, the result was negative. In the bone marrow micronucleus test, the rate of the formation of micronuclei between male and female in each dose group was not significantly different from the negative control (P> 0.05), and the result was negative. There was no significant difference between the experimental group and the negative control group in the sperm deformity test (all P> 0.05), and the sperm abnormality test result was negative. Conclusion Recombinant gAd protein belongs to the actual non-toxic substances and has no genotoxic effect.